FDA: More than 500 deaths reportedly connected to recalled Philips Respironics devices
Click Here to Manage Email Alerts
As of Sept. 30, 2023, there have been 561 reported deaths reportedly connected to recalled Philips Respironics devices, according to an update from the FDA.
In June 2021, Philips Respironics recalled 15 million ventilators, bilevel positive airway pressure machines and CPAP machines because polyester-based polyurethan (PE-PUR) sound abatement foam could break down and enter the device’s air pathway, subsequently to be swallowed or inhaled by the user of the device.
Between 2011 and April 2021, the FDA received 30 medical device reports (MDRs) related to these Philips Respironics devices. At that point, no reports indicated death or patient injury.
However, new information from the FDA shows that 116,000 MDRs connected to these recalled devices have been submitted since April 2021, including 561 reports of deaths and multiple types of injuries (cancer, pneumonia, asthma, infection, headache, cough, dyspnea, dizziness, nodules and chest pain).
Importantly, the FDA indicates limitations with MDRs, writing “the incidence, prevalence or cause of an event cannot typically be determined from this reporting system alone.”
“The vast majority (approximately 93%) of the MDRs filed since April 2021 up to and including December 2023 are alleged malfunctions that do not involve reported serious injury or death,” Steve Klink, PhD, head of global external relations at Philips, told Healio. “Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these MDRs.”
Klink told Healio that Philips Respironics has prioritized patients’ health and well-being since the recall was declared and provided replacement devices to those impacted by the announcement.
“To date, more than 99% of the sleep therapy device registrations globally that are complete and actionable have been remediated,” Klink said.
The company also reports conducting a comprehensive test program on the PE-PUR foam to gain a clear understanding of any harms associated with it.
“Together with five independent certified testing laboratories and qualified third-party experts, Philips Respironics has been conducting a comprehensive test program on the PE-PUR foam,” Klink told Healio. “Based on the testing and analysis to date, Philips Respironics concluded that use of its sleep therapy devices with PE-PUR foam is not expected to result in appreciable harm to health in patients.”
With regard to cancer being reported as an injury, Klink said several studies featuring devices from the company have not reported a higher risk for this disease with device use.
“Independent of Philips Respironics, 13 epidemiological studies found no association between use of PAP devices, including Philips Respironics PAP devices, and increased risk of cancer in patients with obstructive sleep apnea,” Klink told Healio.
According to the FDA update, “The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.”
Notably, Healio recently reported that Philips Respironics will stop selling its sleep therapy and respiratory care devices in the U.S. until it meets the demands of a consent decree from the FDA.
Perspective
Back to Top
Certainly, one lesson we have learned from the Philips recall is to not have all our eggs in one proverbial CPAP basket. I am hopeful that some of the newer brands with smaller footprints will be able to develop monitoring software to facilitate the care of these patients.
Patient care remains a priority, and any new PAP device will be heavily scrutinized. If they prove to be robust and reliable, and if they allow for remote patient monitoring, I anticipate that they will be welcomed into this space.
Our patients are our priority. It’s important to recognize that Philips provides more than PAP devices. The company supplies diagnostic equipment for use in the sleep lab (polysomnography) and at home (home sleep apnea tests). Halting the sale of these devices significantly impacts our ability to diagnose sleep disorders.
The Philips recall has had widespread ramifications from diagnosis to treatment and follow-up care, essentially impacting every single step of diagnosing and treating sleep-disordered breathing. This is a significant burden to the field of sleep medicine.
Collapse
Click Here to Manage Email Alerts